Responsible for structuring and populating MFG applications (SAP, AGILE) with new product information such as part numbers, bill of materials, and other product related information. The new product information will come from various internal customers, including; Operations, Engineering, and Finance. The information will be checked for completeness and integrity, as processed through Document Control’s Change Control process. The candidate should possess the technical aptitude and knowledge to work within these structures, functions, and applications in order to adequately and efficiently support a high volume Medical Research & Development and Manufacturing environment.
• Will assist in the entry and maintenance of all product documentation, as well as, ensure timely, thorough, and accurate release of Change Orders, and Manufacturing Change Orders processed through Agile and SAP.
• Ensure processes for maintaining controlled quality system and product documentation in electronic format (e.g. drawings, procedures, Bills of materials, spec, technical literature and etc.) are well defined to meet company business management system requirements.
• Ensure accuracy and integrity of data maintained in Document Control databases.
• Lead and manage Change Control Board (CCB) meetings.
• Will support Document Control customers in achieving targeted product launch schedules.
• Will be held responsible for integrity and accuracy of data entered into MRP/ERP databases as dictated by electronic Change Orders.
• Ensure processes for maintaining controlled quality system and product documentation in electronic/hard copy format (e.g. drawings, procedures, quality system records, bills of materials, specs, technical literature and etc.) are well defined to meet company business management system requirements.
• Will assist in performing Agile PLM and other departmental training sessions, upon request.
• Will develop and review procedures, and other quality system documentation to ensure adherence to Good Manufacturing Practice (GMP), ISO 13485 requirement, or other related procedures.
• Will assist with creating and maintaining relevant Document Control metrics and reports.
• Provide administrative/project support related to documentation system requirements.